Therapeutic Effect of Immunoadsorption for Patients With Lipoprotein Glomerulopathy

May 25, 2010 updated by: Nanjing University School of Medicine

Therapeutic Effect of Immunoadsorption for Patients With Lipoprotein

The purpose of this study is to assess the efficacy and safety of immunoadsorption in the treatment of lipoprotein glomerulopathy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Lipoprotein glomerulopathy is characterized by nephritic syndrome glomerular protein thrombi and lipid abnormalities, particularly with an elevated level of plasma apoprotein E (apoE).There are no efficiency way to treat lipoprotein glomerulopathy. We firstly successfully treat 2 patients by protein A immunoadsorption with remarkable decreased urine protein and reduction of lipoprotein thrombi on repeated renal biopsy.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210002
        • Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 60 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. A new diagnosis of lipoprotein glomerulopathy proved by histology and serology
  2. Age 15~60 years, sex free

Exclusion Criteria:

  1. Serum creatinine > 500 umol/l
  2. Severe viral infection(HBV, HCV, CMV) within 3 months of first randomization or known HIV infection
  3. Congenital or acquired immunodeficiency
  4. Patients with severe infection or central nervous system symptoms
  5. Immediately life-threatening organ manifestations (e.g. lung haemorrhage or massive gastro-intestinal bleeding, heart failure due to pericarditis or myocarditis, liver dysfunction measured on at least 2 separate occasion)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: immunoadsorption
Procedure: immunoadsorption
immunoadsorption

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To assess the efficacy of immunoadsorption in the treatment of lipoprotein glomerulopathy.
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
To assess the safety of immunoadsorption in the treatment of lipoprotein glomerulopathy.
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing University School of Medicine

Investigators

  • Principal Investigator: Zhi-hong Liu, M.D., Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2000

Primary Completion (ACTUAL)

March 1, 2002

Study Completion (ACTUAL)

August 1, 2003

Study Registration Dates

First Submitted

March 13, 2006

First Submitted That Met QC Criteria

March 13, 2006

First Posted (ESTIMATE)

March 14, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

May 27, 2010

Last Update Submitted That Met QC Criteria

May 25, 2010

Last Verified

July 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NJCT-0608

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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